GMP: Current FDA\'s Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

In a first stage of escalation - when serious GMP deviations are identified during inspections, or in case of insufficient corrective measures - the FDA issues a Warning Letter to the companies concerned. Within 15 working days, the companies in question have to undertake concrete action plans to redress those deviations. If these action plans are evaluated as insufficient by the Agency, further escalation levels may follow.